Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

ACTRNACTRN12620000008921 : A Phase I, Open-Label, Multiple Ascending Dose Study of the Safety and Tolerability of T3011 in advanced Cutaneous or Subcutaneous Malignancies

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Sarcoma,SkinBasal cell carcinoma,Cutaneous Squamous Cell Carcinoma (CSCC),Ewing's Sarcoma,Gastrointestinal stromal tumour (GIST),Leiomyosarcoma,Liposarcoma,Melanoma (Skin),Rhabdomyosarcoma,Sarcoma,Soft Tissue Sarcoma,Squamous cell carcinoma ,Synovial Sarcoma

Trial Overview Read MoreRead more

This Phase I trial is trying to understand how safe and tolerable a targeted therapy (T3011) is in people with advanced cancers.
 

This trial is treating patients with advanced cutaneous or subcutaneous cancers.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase I, Open-Label, Multiple Ascending Dose Study of the Safety and Tolerability of T3011 in advanced Cutaneous or Subcutaneous Malignancies

Commercial Sponsor

Immvira Pharma Co Ltd

Summary

This is a non-randomised dose escalation study. Participants will receive T3011 at the assigned dose level by intratumoural injection commencing on W1D1, and approximately every 14 days thereafter (ie: W3D1, W5D1 etc) for up to 2 years (unless disease progression, unacceptable toxicity, death or withdrawal of consent). The starting dose of T3011 is 1.0 × 10^6 PFU/mL with the volume injected intratumourally based on tumour size, but not exceeding a total of 4 mls for each visit for all tumours combined. The study uses a 3+3 dose escalation design to evaluate escalating doses of T3011 monotherapy. Three additional doses are planned to be tested (1.0 × 10^7, 5.0 × 10^7, and 1 × 10^8 PFU/ml). At any dose level, if no dose-limiting toxicity (DLT) occurs among the first 3 participants, then escalation to the next dose level may proceed if approved by the Safety Review committee (SRC). If 1 DLT occurs in the first 1 to 3 participants, the dose level will expand to a maximum of 6 participants. If no DLT occurs among the additional participants, then escalation to the next dose level may proceed if approved by the SRC. The non-tolerated dose (NTD) is the dose level at which 2 or more participants experience a DLT during the DLT evaluation period. The maximum tolerated dose (MTD) will be defined as the dose level immediately below the NTD. At least 6 participants will be treated at the MTD before expansion to Part 2 (Dose Expansion) with additional participants treated with a dose selected by the SRC.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Medical Oncology
Prahran
Ms Eleanor Edwards
El.Edwards@alfred.org.au
03 9076 2297

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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